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Instant and Lasting Relief Effects of Strontium Chloride/Potassium Nitrate Dentifrice on Dentin Hypersensitivity

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ClinicalTrials.gov Identifier: NCT01426360
Recruitment Status : Completed
First Posted : August 31, 2011
Results First Posted : December 19, 2011
Last Update Posted : December 19, 2011
Sponsor:
Information provided by (Responsible Party):
Liu Hongchun, Sun Yat-sen University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dentine Hypersensitivity
Interventions Other: control dentifrice
Other: strontium chloride/potassium nitrate dentifrice
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Strontium Chloride/Potassium Nitrate Dentifrice Control Dentifrice
Hide Arm/Group Description Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group) Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
Period Title: Overall Study
Started 38 41
Completed 38 41
Not Completed 0 0
Arm/Group Title Strontium Chloride/Potassium Nitrate Dentifrice Control Dentifrice Total
Hide Arm/Group Description Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group) Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group) Total of all reporting groups
Overall Number of Baseline Participants 38 41 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 41 participants 79 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
 100.0%
41
 100.0%
79
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 41 participants 79 participants
42.37  (8.8) 43.39  (8.8) 42.9  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 41 participants 79 participants
Female
27
  71.1%
28
  68.3%
55
  69.6%
Male
11
  28.9%
13
  31.7%
24
  30.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 38 participants 41 participants 79 participants
38 41 79
Baseline tactile hypersensitivity score   [1] 
Mean (Standard Deviation)
Unit of measure:  Gram
Number Analyzed 38 participants 41 participants 79 participants
12.63  (5.16) 12.2  (3.72) 12.41  (4.45)
[1]
Measure Description: Tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified, reproducible force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.
Baseline air blast hypersensitivity score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 38 participants 41 participants 79 participants
2.42  (0.41) 2.46  (0.41) 2.44  (0.41)
[1]
Measure Description:

The tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at the exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects’ response.

0 - Subject does not respond to air stimulus;

  1. - Subject responds to air stimulus, but does not request discontinuation of stimulus;
  2. - Subject responds to air stimulus and requests discontinuation or moves from stimulus;
  3. - Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
1.Primary Outcome
Title Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use
Hide Description Immediately after dentifice use, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.
Time Frame immediately after dentifrice use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strontium Chloride/Potassium Nitrate Dentifrice Control Dentifrice
Hide Arm/Group Description:
Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
Overall Number of Participants Analyzed 38 41
Mean (Standard Deviation)
Unit of Measure: gram
19.47  (14.69) 14.27  (5.76)
2.Primary Outcome
Title Air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use
Hide Description

The tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at the exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects’ response.

0 - Subject does not respond to air stimulus;

  1. - Subject responds to air stimulus, but does not request discontinuation of stimulus;
  2. - Subject responds to air stimulus and requests discontinuation or moves from stimulus;
  3. - Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time Frame immediately after dentifrice use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strontium Chloride/Potassium Nitrate Dentifrice Control Dentifrice
Hide Arm/Group Description:
Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
Overall Number of Participants Analyzed 38 41
Mean (Standard Deviation)
Unit of Measure: scale
1.93  (0.51) 2.22  (0.6)
3.Primary Outcome
Title Tactile Hypersensitivity Score After 3 Days of Dentifrice Use
Hide Description After 3 days, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified, reproducible force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.
Time Frame 3 days after dentifrice use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strontium Chloride/Potassium Nitrate Dentifrice Control Dentifrice
Hide Arm/Group Description:
Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
Overall Number of Participants Analyzed 38 41
Mean (Standard Deviation)
Unit of Measure: gram
19.87  (14.95) 14.27  (5.98)
4.Primary Outcome
Title Air Blast Hypersensitivity Score 3 Days After Dentifrice Use
Hide Description

After 3 days, tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects’ response.

0 - Subject does not respond to air stimulus;

  1. - Subject responds to air stimulus, but does not request discontinuation of stimulus;
  2. - Subject responds to air stimulus and requests discontinuation or moves from stimulus;
  3. - Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time Frame 3 days after dentifrice use
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Strontium Chloride/Potassium Nitrate Dentifrice Control Dentifrice
Hide Arm/Group Description:
Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
Overall Number of Participants Analyzed 38 41
Mean (Standard Deviation)
Unit of Measure: scale
1.8  (0.56) 2.13  (0.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Strontium Chloride/Potassium Nitrate Dentifrice Control Dentifrice
Hide Arm/Group Description Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group) Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
All-Cause Mortality
Strontium Chloride/Potassium Nitrate Dentifrice Control Dentifrice
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Strontium Chloride/Potassium Nitrate Dentifrice Control Dentifrice
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Strontium Chloride/Potassium Nitrate Dentifrice Control Dentifrice
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/41 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Liu Hongchun
Organization: Sun Yat-sen University
Phone: 86-0-13826189071
EMail: hongchun751@sina.com
Layout table for additonal information
Responsible Party: Liu Hongchun, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01426360     History of Changes
Other Study ID Numbers: DH-38
First Submitted: August 29, 2011
First Posted: August 31, 2011
Results First Submitted: October 1, 2011
Results First Posted: December 19, 2011
Last Update Posted: December 19, 2011